Clinical TrialSingle-armSuicidalityKetamineTerminated

Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot

Randomized, triple-blind Phase IV trial (n=200) testing a single IV ketamine 0.5 mg/kg infusion plus computer-based cognitive training versus sham training and treatment-as-usual in medically hospitalized suicidal patients.

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Target Enrollment
16 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

This study evaluates the acute and longer-term impact of a single subanesthetic IV ketamine infusion (0.5 mg/kg) in suicidal medical inpatients and tests whether computer-based cognitive training (8 sessions) can extend ketamine's rapid effects.

Design: randomized, parallel-group, triple-masked, four-arm trial comparing ketamine with sham training, ketamine with active training, and TAU variants; primary aims focus on suicidality outcomes and trajectories over predefined time windows per registry clarifications.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

8 sessions

Therapeutic Protocol

other

Study Arms & Interventions

Ketamine-treated sample

experimental

Pooled open-label ketamine-treated sample from the published pilot; patients were randomized only to active versus sham cognitive training, which was pooled for analysis.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total
  • Compound
    via Other• 4 days

    Brief automated cognitive training or sham training; groups pooled in the publication.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Participants who receive ketamine will:
  • 1. be between the ages of 18 and 70 years
  • 2. be a medical inpatient referred for psychiatric consultation/liaison due to suicidality and determined by psychiatric C/L to require follow-up psychiatric care (inpatient or outpatient)
  • 3. possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document
  • 4. be deemed an appropriate and reasonable medical candidate for intravenous ketamine by a physician authorized to prescribe medication to the patient during inpatient hospitalization

Exclusion Criteria

  • 1. Presence of current/acute psychosis with significant thought disruption, mania, delirium, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment
  • 2. Mini-Mental State Exam (MMSE) < 21
  • 3. Current pregnancy or breastfeeding
  • 4. Reading level <5th grade as per WRAT-3 reading subtest AND patient declines to have all questionnaire items and task instructions read aloud to them at all assessment points
  • 5. Past intolerance or hypersensitivity to ketamine or esketamine
  • 6. Patients taking St John's Wort
  • 7. Patients who have received ECT in the past 1 month prior to intake
  • 8. Patients at ongoing risk for severe substance or alcohol withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis
  • 9. Arrested or incarcerated individuals brought in by the legal system for medical stabilization

Study Details

  • Status
    Terminated
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment16 participants
  • Timeline
    Start: 2019-12-19
    End: 2022-03-15
  • Compound
    Ketamine
  • Topic
    Suicidality

Locations

University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Related Publications

Open AccessindividualPrimary

A Pilot Study of Ketamine Infusion after Suicide Attempt: New Frontiers in Treating Acute Suicidality in a Real-World Medical Setting

In an open‑label pilot of 16 medically hospitalised recent suicide attempters, a single intravenous ketamine infusion (0.5 mg/kg) produced rapid, large reductions in suicidality and depression at 24 hours and 5 days (Cohen’s d 1.7–8.8) that were sustained up to six months. The study indicates ketamine is a feasible, rapidly acting intervention for acute suicidality in real‑world Consultation‑Liaison settings.

Published
Journal
International Journal of Environmental Research and Public Health
Authors
Shivanekar, S., Pizon, A., Spotts, C., Cruz, N., Lightfoot, M., Rohac, R., Baumeister, A., Griffo, A., Panny, B., Kucherer, S., Israel, A., Rengasamy, M., Price, R., Goplan, P.